Hologic, Inc. · 7 hours ago
Quality Engineer 2
San Diego, CA
Full-time
Onsite
Entry, Mid Level
$78K/yr - $122K/yr
2+ years expHologic, Inc. is a company dedicated to enhancing the quality of life through innovative medical technologies. They are seeking a Quality Engineer II to ensure compliance and quality throughout the manufacturing lifecycle of diagnostic and medical device products, leading validation efforts and driving process improvements.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead validation efforts for analytical methods, equipment, processes, and facilities
Drive risk management and support regulatory submissions
Collaborate cross-functionally and contribute to new product introductions
Champion process improvements
Qualification
Required
Proficient understanding of validation methods, including process validation, analytical method validation, cleaning validation, and equipment/facility qualification
Knowledge of risk analysis tools such as PFMEA and process risk assessments
Working knowledge of regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11
Familiarity with change control processes and documentation requirements
Understanding of statistics, Statistical Process Control (SPC), and acceptance sampling plans
Strong technical writing skills for authoring validation protocols, reports, master validation plans, and regulatory submission content
Ability to perform validation impact assessments and determine risk-based validation strategies
Experience with electronic document management systems
Proficient in leading cross-functional teams to develop PFMEAs and address process-related non-conformance events
Excellent analytical and problem-solving skills to evaluate specifications and propose improvement projects
Strong interpersonal and collaboration skills to work effectively across departments and with cross-functional teams
Project management skills, including the ability to determine deliverables, set timelines, and manage departmental or cross-department projects
Detail-oriented and organized with a focus on accuracy and compliance
Proactive and solution-oriented, with a continuous improvement mindset to enhance processes and procedures
Collaborative team player who fosters strong partnerships across functions
Accountable and self-motivated, able to operate with limited supervision and escalate issues as needed
Committed to training and mentoring new employees to ensure team success
Adaptable and able to manage competing priorities in a fast-paced, regulated environment
2–5 years of experience in a diagnostic, medical device, biotech, or pharmaceutical company
Hands-on experience with validation activities, including analytical method validation, process validation, and equipment/facility qualifications
Experience with regulatory submissions and understanding of quality systems in regulated industries
Practical experience with risk management, including PFMEAs and process risk assessments
Familiarity with change control processes and electronic document management systems
Benefits
Comprehensive training when you join
Continued development and training throughout your career
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-17
Company data provided by crunchbase